Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study

on behalf of the MACUSTAR consortium

doi:10.1186/s12874-021-01243-8

Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study

on behalf of the MACUSTAR consortium

School of Medicine, Dentistry and Biomedical Sciences

Research output: Contribution to journal › Article › peer-review

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Abstract

Background:

Recruiting asymptomatic participants with early disease stages into studies is challenging and only little is known about facilitators and barriers to screening and recruitment of study participants. Thus we assessed factors associated with screening rates in the MACUSTAR study, a multi-centre, low-interventional cohort study of early stages of age-related macular degeneration (AMD).

Methods:

Screening rates per clinical site and per week were compiled and applicable recruitment factors were assigned to respective time periods. A generalized linear mixed-effects model including the most relevant recruitment factors identified via in-depth interviews with study personnel was fitted to the screening data. Only participants with intermediate AMD were considered.

Results:

A total of 766 individual screenings within 87 weeks were available for analysis. The mean screening rate was 0.6 ± 0.9 screenings per week among all sites. The participation at investigator teleconferences (relative risk increase 1.466, 95% CI [1.018–2.112]), public holidays (relative risk decrease 0.466, 95% CI [0.367–0.591]) and reaching 80% of the site’s recruitment target (relative risk decrease 0.699, 95% CI [0.367–0.591]) were associated with the number of screenings at an individual site level.

Conclusions:

Careful planning of screening activities is necessary when recruiting early disease stages in multi-centre observational or low-interventional studies. Conducting teleconferences with local investigators can increase screening rates. When planning recruitment, seasonal and saturation effects at clinical site level need to be taken into account.

Original language	English
Article number	54
Number of pages	8
Journal	BMC Medical Research Methodology
Volume	21
DOIs	https://doi.org/10.1186/s12874-021-01243-8
Publication status	Published - 17 Mar 2021

Bibliographical note

Funding Information:
All institutional ethic committees approved the study and participants gave written informed consent prior to participation. The MACUSTAR project receives funding from the European Union Innovative Medicines Initiative (IMI2) Horizon 2020 programme. It has been registered at the website clinicaltrials.gov with the identifier NCT03349801. Inclusion criteria for this analysis were individuals screened for the MACUSTAR study with the screening diagnosis intermediate AMD, a high-risk type of the early AMD stages (determined at the clinical site). Study inclusion at all study sites was based on the evaluation and confirmation of AMD diagnosis by a central reading centre, as described previously []. Exclusion criteria were missing informed consent, participation in any of the other MACUSTAR study groups (early, or late AMD or control group) or relocation to another clinical site within the time of the study. The MACUSTAR clinical study is managed by the academic clinical research organization AIBILI (Association for Innovation and Biomedical Research on Light and Image, www.aibili.pt ) and monitored by the European distributed infrastructure network ECRIN-ERIC ( www.ecrin.org ).

Funding Information:
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 116076. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Open Access funding enabled and organized by Projekt DEAL.

Publisher Copyright:
© 2021, The Author(s).

Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.

Keywords

Age-related macular degeneration
Cohort study
Early disease stages
Recruitment
Screening

ASJC Scopus subject areas

Epidemiology
Health Informatics

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Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study
Copyright 2021 the authors. This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
Final published version, 703 KBLicence: CC BY

Cite this

@article{fe4bcbfb276a44aea2aaa5a5d011cce4,

title = "Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study",

abstract = "Background: Recruiting asymptomatic participants with early disease stages into studies is challenging and only little is known about facilitators and barriers to screening and recruitment of study participants. Thus we assessed factors associated with screening rates in the MACUSTAR study, a multi-centre, low-interventional cohort study of early stages of age-related macular degeneration (AMD).Methods: Screening rates per clinical site and per week were compiled and applicable recruitment factors were assigned to respective time periods. A generalized linear mixed-effects model including the most relevant recruitment factors identified via in-depth interviews with study personnel was fitted to the screening data. Only participants with intermediate AMD were considered. Results: A total of 766 individual screenings within 87 weeks were available for analysis. The mean screening rate was 0.6 ± 0.9 screenings per week among all sites. The participation at investigator teleconferences (relative risk increase 1.466, 95% CI [1.018–2.112]), public holidays (relative risk decrease 0.466, 95% CI [0.367–0.591]) and reaching 80% of the site{\textquoteright}s recruitment target (relative risk decrease 0.699, 95% CI [0.367–0.591]) were associated with the number of screenings at an individual site level. Conclusions: Careful planning of screening activities is necessary when recruiting early disease stages in multi-centre observational or low-interventional studies. Conducting teleconferences with local investigators can increase screening rates. When planning recruitment, seasonal and saturation effects at clinical site level need to be taken into account. ",

keywords = "Age-related macular degeneration, Cohort study, Early disease stages, Recruitment, Screening",

author = "{on behalf of the MACUSTAR consortium} and Terheyden, {Jan Henrik} and Charlotte Behning and Anna L{\"u}ning and Ludmila Wintergerst and Basile, {Pier G.} and Diana Tavares and Mel{\'i}cio, {Beatriz A.} and Sergio Leal and George Weissgerber and Luhmann, {Ulrich F.O.} and Crabb, {D. P.} and Adnan Tufail and C. Hoyng and Moritz Berger and Matthias Schmid and Rufino Silva and Martinho, {Cec{\'i}lia V.} and Jos{\'e} Cunha-Vaz and Holz, {F. G.} and Finger, {R. P.} and H. Agostini and F. Bandello and P. Basile and C. Behning and M. Berger and A. Binns and M. B{\"o}ttger and C. Bouchet and Brazier, {J. E.} and T. Butt and C. Carapezzi and J. Carlton and A. Carneiro and A. Charil and R. Coimbra and Crabb, {D. P.} and J. Cunha-Vaz and C. Dahlke and H. Dunbar and M. Durbin and Finger, {R. P.} and E. Fletcher and H. Floyd and R. Hogg and Holz, {F. G.} and C. Hoyng and J. Kr{\"a}tzschmar and L. K{\"u}hlewein and C. S{\'a}nchez and Taylor, {D. J.}",

note = "Funding Information: All institutional ethic committees approved the study and participants gave written informed consent prior to participation. The MACUSTAR project receives funding from the European Union Innovative Medicines Initiative (IMI2) Horizon 2020 programme. It has been registered at the website clinicaltrials.gov with the identifier NCT03349801. Inclusion criteria for this analysis were individuals screened for the MACUSTAR study with the screening diagnosis intermediate AMD, a high-risk type of the early AMD stages (determined at the clinical site). Study inclusion at all study sites was based on the evaluation and confirmation of AMD diagnosis by a central reading centre, as described previously []. Exclusion criteria were missing informed consent, participation in any of the other MACUSTAR study groups (early, or late AMD or control group) or relocation to another clinical site within the time of the study. The MACUSTAR clinical study is managed by the academic clinical research organization AIBILI (Association for Innovation and Biomedical Research on Light and Image, www.aibili.pt ) and monitored by the European distributed infrastructure network ECRIN-ERIC ( www.ecrin.org ). Funding Information: This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 116076. This Joint Undertaking receives support from the European Union{\textquoteright}s Horizon 2020 research and innovation programme and EFPIA. Open Access funding enabled and organized by Projekt DEAL. Publisher Copyright: {\textcopyright} 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",

year = "2021",

month = mar,

day = "17",

doi = "10.1186/s12874-021-01243-8",

language = "English",

volume = "21",

journal = "BMC Medical Research Methodology",

issn = "1471-2288",

publisher = "BioMed Central",

}

TY - JOUR

T1 - Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study

AU - on behalf of the MACUSTAR consortium

AU - Terheyden, Jan Henrik

AU - Behning, Charlotte

AU - Lüning, Anna

AU - Wintergerst, Ludmila

AU - Basile, Pier G.

AU - Tavares, Diana

AU - Melício, Beatriz A.

AU - Leal, Sergio

AU - Weissgerber, George

AU - Luhmann, Ulrich F.O.

AU - Crabb, D. P.

AU - Tufail, Adnan

AU - Hoyng, C.

AU - Berger, Moritz

AU - Schmid, Matthias

AU - Silva, Rufino

AU - Martinho, Cecília V.

AU - Cunha-Vaz, José

AU - Holz, F. G.

AU - Finger, R. P.

AU - Agostini, H.

AU - Bandello, F.

AU - Basile, P.

AU - Behning, C.

AU - Berger, M.

AU - Binns, A.

AU - Böttger, M.

AU - Bouchet, C.

AU - Brazier, J. E.

AU - Butt, T.

AU - Carapezzi, C.

AU - Carlton, J.

AU - Carneiro, A.

AU - Charil, A.

AU - Coimbra, R.

AU - Crabb, D. P.

AU - Cunha-Vaz, J.

AU - Dahlke, C.

AU - Dunbar, H.

AU - Durbin, M.

AU - Finger, R. P.

AU - Fletcher, E.

AU - Floyd, H.

AU - Hogg, R.

AU - Holz, F. G.

AU - Hoyng, C.

AU - Krätzschmar, J.

AU - Kühlewein, L.

AU - Sánchez, C.

AU - Taylor, D. J.

N1 - Funding Information: All institutional ethic committees approved the study and participants gave written informed consent prior to participation. The MACUSTAR project receives funding from the European Union Innovative Medicines Initiative (IMI2) Horizon 2020 programme. It has been registered at the website clinicaltrials.gov with the identifier NCT03349801. Inclusion criteria for this analysis were individuals screened for the MACUSTAR study with the screening diagnosis intermediate AMD, a high-risk type of the early AMD stages (determined at the clinical site). Study inclusion at all study sites was based on the evaluation and confirmation of AMD diagnosis by a central reading centre, as described previously []. Exclusion criteria were missing informed consent, participation in any of the other MACUSTAR study groups (early, or late AMD or control group) or relocation to another clinical site within the time of the study. The MACUSTAR clinical study is managed by the academic clinical research organization AIBILI (Association for Innovation and Biomedical Research on Light and Image, www.aibili.pt ) and monitored by the European distributed infrastructure network ECRIN-ERIC ( www.ecrin.org ). Funding Information: This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 116076. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Open Access funding enabled and organized by Projekt DEAL. Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/3/17

Y1 - 2021/3/17

N2 - Background: Recruiting asymptomatic participants with early disease stages into studies is challenging and only little is known about facilitators and barriers to screening and recruitment of study participants. Thus we assessed factors associated with screening rates in the MACUSTAR study, a multi-centre, low-interventional cohort study of early stages of age-related macular degeneration (AMD).Methods: Screening rates per clinical site and per week were compiled and applicable recruitment factors were assigned to respective time periods. A generalized linear mixed-effects model including the most relevant recruitment factors identified via in-depth interviews with study personnel was fitted to the screening data. Only participants with intermediate AMD were considered. Results: A total of 766 individual screenings within 87 weeks were available for analysis. The mean screening rate was 0.6 ± 0.9 screenings per week among all sites. The participation at investigator teleconferences (relative risk increase 1.466, 95% CI [1.018–2.112]), public holidays (relative risk decrease 0.466, 95% CI [0.367–0.591]) and reaching 80% of the site’s recruitment target (relative risk decrease 0.699, 95% CI [0.367–0.591]) were associated with the number of screenings at an individual site level. Conclusions: Careful planning of screening activities is necessary when recruiting early disease stages in multi-centre observational or low-interventional studies. Conducting teleconferences with local investigators can increase screening rates. When planning recruitment, seasonal and saturation effects at clinical site level need to be taken into account.

AB - Background: Recruiting asymptomatic participants with early disease stages into studies is challenging and only little is known about facilitators and barriers to screening and recruitment of study participants. Thus we assessed factors associated with screening rates in the MACUSTAR study, a multi-centre, low-interventional cohort study of early stages of age-related macular degeneration (AMD).Methods: Screening rates per clinical site and per week were compiled and applicable recruitment factors were assigned to respective time periods. A generalized linear mixed-effects model including the most relevant recruitment factors identified via in-depth interviews with study personnel was fitted to the screening data. Only participants with intermediate AMD were considered. Results: A total of 766 individual screenings within 87 weeks were available for analysis. The mean screening rate was 0.6 ± 0.9 screenings per week among all sites. The participation at investigator teleconferences (relative risk increase 1.466, 95% CI [1.018–2.112]), public holidays (relative risk decrease 0.466, 95% CI [0.367–0.591]) and reaching 80% of the site’s recruitment target (relative risk decrease 0.699, 95% CI [0.367–0.591]) were associated with the number of screenings at an individual site level. Conclusions: Careful planning of screening activities is necessary when recruiting early disease stages in multi-centre observational or low-interventional studies. Conducting teleconferences with local investigators can increase screening rates. When planning recruitment, seasonal and saturation effects at clinical site level need to be taken into account.

KW - Age-related macular degeneration

KW - Cohort study

KW - Early disease stages

KW - Recruitment

KW - Screening

U2 - 10.1186/s12874-021-01243-8

DO - 10.1186/s12874-021-01243-8

M3 - Article

C2 - 33731014

AN - SCOPUS:85102726539

VL - 21

JO - BMC Medical Research Methodology

JF - BMC Medical Research Methodology

SN - 1471-2288

M1 - 54

ER -

Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

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